Author: MIL OSI Publisher

Question for written answer  E-001582/2025
to the Commission
Rule 144
Emmanouil Fragkos (ECR)

The lack of rainfall in Greece, as in all of southern Europe, over the past two years has exacerbated the problem of water scarcity.

Attica mainly gets its water from the artificial lake of Marathon, which functions as a reservoir, and the drop in its level has led to consideration of the scenario of transferring water from Lake Kremasta (Aetolia-Acarnania). This is the largest lake in Greece and is planned to become the main source of water for transfer to the capital.

However, the artificial lake of Kremasta has seen the creation of a proverbial wetland with many types of birds and intense vegetation – in addition to the natural beauty of the area. The rate of water absorption from there for transfer to the capital is planned to be 5% of the water, but this may increase, as the problem has not been definitively resolved. The channelling of water from there to Athens, which will require significant investment, also carries the risk of disturbing the ecosystem that has formed, disrupting the whole lake.

In light of the above:

• 1.Does the Commission intend to monitor the requirements of the studies and the possible execution of the project, which carries the risk of disrupting the ecosystem?
• 2.Does a framework exist for an artificial lake to become a protected area?
• 3.How can the Commission ensure that the ecological balance is not disrupted by such actions, even if their aim is to resolve such a serious issue as water scarcity?

Submitted: 21.4.2025

The Commission is committed to further harmonising EU legislation on food contact materials (FCMs), as indicated in its announcement to revise the legislation[1]. The Commission has recognised the need to significantly reduce the current EU limits for lead and cadmium allowed to transfer into food from ceramic materials, to widen the scope to other types of materials including glass and enamels, and to consider limits for other metals to safeguard public health.

The Commission has already carried out a significant body of work on this initiative, including the development of adequate methodologies for testing[2], an inception impact assessment[3] and direct stakeholder dialogue as well as technical discussions with Member States.

Further preparatory work for the initiative is ongoing, which is highly complex and requires further consultations with all relevant stakeholders to ensure the coherence of requirements across different types of FCMs, in particular the approach to regulating particularly hazardous substances but considering also the potential impacts on small and medium enterprises (SMEs) and producers using traditional production techniques.

• [1] https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en
• [2] https://publications.jrc.ec.europa.eu/repository/handle/JRC102075
• [3] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/2074-Food-safety-heavy-metals-in-ceramic-glass-and-enameled-table-and-kitchenware_en

Regulation (EU) 2017/745 on medical devices[1] (MDR) defines ‘custom-made devices’ in Article 2(3) and provides for legal exceptions for certain mass-produced devices.

Accordingly, it would depend on the specific case whether clear aligners — also known as invisible braces — may be actually considered as custom-made devices or rather mass-produced devices.

The Medical Device Coordination Group (MDCG) established under Article 103 of the MDR endorsed the guidance document ‘MDCG 2021-3 Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices’[2] where ‘orthotic braces’ are mentioned as examples of ‘mass-produced adaptable medical devices’, not considering them as custom-made devices.

This reflects the situation on the market, where the use of clear aligners is largely extended as adapted devices from mass-produced devices, as well as the views of other international regulatory frameworks[3]^,[4].

Both custom-made devices and mass-produced adaptable medical devices need the prescription of authorised healthcare professionals with respect to their specific characteristics and the needs of patients.

Therefore, the possibility to purchase clear aligners or invisible braces without consulting a healthcare structure or professional may indeed represent a risk for patients as well as a competitive disadvantage for healthcare manufacturers and professionals.

The responsibility for market surveillance and vigilance on the appropriate placing on the market and use of those devices belongs to the national competent authorities of the Member States in the field of medical devices[5].

• [1]  OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj
• [2] https://health.ec.europa.eu/document/download/385d7e20-d8b5-49d0-abd7-8daf269bf1b8_en?filename=mdcg_2021-3_en.pdf
• [3] For instance, the Australian Therapeutic Goods Administration considers aligners as ‘patient-matched medical devices’, not custom-made devices. See https://www.tga.gov.au/resources/guidance/understanding-personalised-medical-devices-rules-including-3d-printed-devices#patientmatched-medical-devices
• [4] See the guidance on ‘Personalized Medical Devices (PMD)’ by the International Medical Device Regulatory Forum (IMDRF) https://www.imdrf.org/working-groups/personalized-medical-devices
• [5] https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en#national-competent-authorities

Article 11 of Directive 2011/95/EU[1] sets out the grounds for considering that a third-country national has ceased to be a refugee or a person eligible for subsidiary protection. This is also provided for by Article 11 of Regulation (EU) 2024/1347[2], which requires that determining authorities also take into account precise and up-to-date information obtained from relevant and available sources. The assessment of whether the conditions for international protection have ceased is to be undertaken on an individual basis, taking into account the specific circumstances of the beneficiary.

Article 31(4) of Directive 2013/32/EU[3] allows Member States to postpone concluding the examination procedure due to an uncertain situation in the country of origin which is expected to be temporary. The Commission is monitoring the situation and has been informed by the relevant Member States about this suspension.

The Commission continues to work closely with the United Nations (UN) High Commissioner for Refugees to ensure that returns are voluntary, safe and dignified, and with other UN partners to help create the conditions inside Syria for people to return.

• [1] Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted, OJ L 337, 20.12.2011, p. 9-26, http://data.europa.eu/eli/dir/2011/95/oj
• [2] Regulation (EU) 2024/1347 of the European Parliament and of the Council of 14 May 2024 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection and for the content of the protection granted, amending Council Directive 2003/109/EC and repealing Directive 2011/95/EU of the European Parliament and of the Council, OJ L, 2024/1347, 22.5.2024, http://data.europa.eu/eli/reg/2024/1347/oj
• [3] Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (recast), OJ L 180, 29.6.2013, p. 60-95, http://data.europa.eu/eli/dir/2013/32/oj

The European Contact Group on Search and Rescue consists of Member States and Schengen Associated Countries and provides them with a space for dialogue as well as a framework to liaise with relevant stakeholders, including private entities owning or operating vessels for the purpose of search and rescue activities, such as non-governmental organisations[1].

The Commission holds regular meetings with non-governmental organisations on search and rescue related issues, which have also informed the work of the Contact Group.

• [1] Commission Recommendation (EU) 2020/1365 on cooperation among Member States concerning operations carried out by vessels owned or operated by private entities for the purpose of search and rescue activities, points (16) and (2), OJ L 317, 1.10.2020, p. 23-25.

The President of the Commission tasked the High Representative and the Commissioner for Defence and Space to put forward a White Paper for European Defence Readiness 2030 within the first 100 days of the new mandate[1]. The College adopted it on 19 March 2025[2].

The White Paper frames a new approach to defence and defence industry and identifies related investment needs. It addresses closing critical capability gaps, ramping-up European defence production and mobilising additional funding for defence.

For the EU to provide tailored support to ramp-up defence industrial production capacities, it is important to have a clear picture of Member States’ capability targets, to translate them into industrial ones. This approach is summarised as an industrial output plan.

Following the publication of the White Paper , consultations with all key stakeholder’s kicked-off , including with Member States , the European Parliament and Defence Industry , but also partners such as the North Atlantic Treaty Organisation (NATO).

The EU will also support Member States in defining projects to address the critical capability gaps, starting with the priorities identified by the European Council on 6 March 2025.

The outcome of these consultations will determine the way forward implementation of the embedded in , including how to further support ramping-up defence industrial production capacities.

EU and NATO are in contact and hold structured dialogues on topics including emerging disruptive technologies and defence industrial matters.

Under this framework they have regularly exchanged information on relevant ongoing activities, including the Defence Innovation Accelerator for the North Atlantic and the NATO Support and Procurement Agency.

• [1] https://commission.europa.eu/document/download/1f8ec030-d018-41a2-9759-c694d4d56d6c_en?filename=Mission%20letter%20-%20KUBILIUS.pdf
• [2] https://defence-industry-space.ec.europa.eu/document/download/30b50d2c-49aa-4250-9ca6-27a0347cf009_en?filename=White%20Paper.pdf

1. Despite significant progress in cross-border cooperation against financial crimes, it is important that Member States systemically launch financial investigations when investigating serious criminal offenses. Swift transposition of the new Directive on asset recovery[1] will ensure that asset-tracing is part of all investigations into organised crime. The new rules on exchange of information[2] also boost police cooperation against financial crime. Europol and Eurojust support operational cooperation to tackle financial crimes, and the European Public Prosecutor’s Office (EPPO) prosecutes crimes, playing a key role in dismantling criminal activities across the EU, while OLAF, the European Anti-Fraud Office, complements these efforts by detecting, investigating, and preventing fraud, both affecting the EU’s financial interests.

2. Acting as the ‘information hub’ for EU law enforcement, Europol provides the EPPO access to information from national law enforcement authorities stored in its information system. The Commission will take into account the cooperation with EPPO, and the need to further enhance it, when evaluating the current legal framework for Europol[3], and in any proposals that may follow.

3. The Commission has launched reflections, supported by the High-Level Forum on the Future of EU Criminal Justice[4], on areas in which the EPPO will need more powers to look at cross-border serious crime, in particular corruption that impacts EU funds and cannot be handled alone by Member States . The EPPO’s role, and cooperation with Eurojust and Europol, will also be considered.

• [1] OJ L, 2024/1260, 2.5.2024.
• [2] OJ L 134, 22.5.2023, p. 1-24.
• [3] OJ L 135, 24.5.2016, p. 53, as amended in 2022 OJ L 169, 27.6.2022, p. 1.
• [4] https://ec.europa.eu/commission/presscorner/detail/en/speech_25_745

In 2025, the Commission will focus on scaling up Global Gateway through the implementation of ongoing Global Gateway investment projects and the identification of new sustainable, high-impact investments that will further strengthen EU partnerships with third countries.

The second Global Gateway Forum, to be held in June 2025, will also be a key moment in 2025 to showcase steps being taken to scale up Global Gateway.

The Commission will continue its active engagement with Member States, their cooperation agencies and development financing institutions to emphasise the necessity of building a Team Europe approach to scaling up investments.

The Commission will also continue its work to enhance the coordination of its and Member States financial tools, including those of export credit agencies, and to increase collaboration with the European private sector through investment facilitation mechanisms and business matchmaking initiatives.

The Commission tracks and reports on EU support to Global Gateway investment projects through the annual report on the implementation of the EU’s external action instruments, as well as providing information through a dedicated public website[1].

Global Gateway flagship projects which have been identified by the European Council as projects which showcase Global Gateway, are monitored by the Council’s Working Party of Foreign Relations Counsellors.

In addition, regular exchanges take place between the Commission and the European Parliament, notably the Committee on Development.

• [1] https://international-partnerships.ec.europa.eu/policies/global-gateway_en